Meeting the EU CTR Compliance Challenge Head-On

Many clinical trial sponsors are so focused on initial submission and updates of their studies on government registries in an accurate and timely manner that, once a study is completed, they often neglect to post the final results. This is particularly problematic with European registries, which are complicated, confusing, and inconsistent in format.

The numbers don’t lie. Looking at public data on EU CTR as of July 16, a TrialScope analysis found a total of the over 16,000 studies that ended more than 12 months earlier, only around 10,000 had results posted.

Common errors found in clinical trial results posted on European registries include:

Studies with multiple global completion dates

Dates missing for completed studies

Studies listed as ongoing, although they have ended

Some of these errors can be attributed the difficulty of tracking who is responsible for disclosure due to:

Complex corporate structures (parent organizations, affiliates)

Corporate reorganizations (acquisitions, divestitures)

Compounding the problem is the size of the sponsor organization. Mid-size and smaller sponsors are less likely to post results, for several reasons:

They simply don’t have the bandwidth to keep up with submission demands

It’s not a priority for these organizations

They assume there’s more scrutiny of larger sponsors

The TrialScope analysis of EU CTR data revealed the following in terms of missing European study results:

Non-industry sponsors were the biggest offenders, with over 75 percent of results missing

Next came small industry, at about 65 percent

This was followed by mid-market sponsors, at close to 30 percent

Last was the top 50 industry sponsors, at less than 10 percent

So what exactly is required for EU CTR submission? The following table is an abbreviation of the requirements for trials that ended on or after July 24, 2014. Details and requirements for older studies are available at eudract.ema.europa.eu.

Failure to report clinical trials results is not limited to EudraCT and other regional sites. In an article published early this year, STAT examined nearly 18,700 clinical trials whose results — based on publicly available data — should have been posted to the U.S.-based ClinicalTrials.gov between 2008 and Sept. 11, 2017. Overall, trial sponsors had disclosed 72 percent of required results to the federal ClinicalTrials.gov database as of September 2017. That compares with 58 percent just two years earlier. However, results for four in every 10 trials were reported after the legal deadline — one year following a trial’s completion or termination.

Noncompliant sponsors have several courses of action they can take regarding submission of clinical trial results. They can choose to do nothing, and keep their collective fingers crossed that their noncompliance will slip under the radar. Or, they can take a more proactive (in most cases, retro­-active) approach, starting by listing all EU studies. Then they must assess disclosure deadlines. Next, they can collect available trial information and prioritize based on past due and upcoming deadlines. All of this should be predicated, of course, on organizational SOPs and guidelines on disclosure and transparency. Implementation of technology to streamline the entire process can eliminate the headaches inherent to clinical trial results submission.

About the Author

Thomas is responsible for tracking regulatory and market trends that shape TrialScope’s clinical trial disclosure and transparency solutions. He has more than 23 years of experience with performance and content management solutions, specializing in applications for life sciences such as clinical trial disclosure, structured product labeling and submissions management. Thomas has been focused on trial transparency since 2007.